CEDH · CASELAW;CLIN;ENG — 26 juin 2025

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Spain - 5742/22 Judgment 26.6.2025 [Section V] Article 8 Positive obligations Article 8-1 Respect for private life Applicant’s claim concerning the absence of valid informed consent for the expansion of the scope of her breast-conserving surgery: violation [This case was referred to the Grand Chamber on 3 November 2025] Facts – In June 2016 the applicant was diagnosed with breast cancer. In February 2017 she signed an informed consent form, agreeing to breast-conserving surgery as proposed by the hospital. During her surgery, two samples of breast tissue were immediately analysed, and the decision was made to remove the nipple-areola complex (NAC). In September 2017 the applicant complained to the Health Department of the Madrid Autonomous Community. She claimed 100,000 euros in compensation, asserting that her nipple and areola had been removed although no cancer had been present there, and that she had given informed consent only to the breast-conserving surgery and the removal of lymph nodes. In the absence of a reply to her administrative complaint, the applicant lodged a civil claim with the Madrid High Court of Justice (“High Court”). In September 2020 the High Court considered that the informed consent form signed by the applicant had been sufficient because it concerned breast-conserving surgery in which the primary objective had been to remove the cancer; that objective had been the reason for modifying the technique; and the informed consent form stated that the technique could be modified if anything unforeseen occurred. Furthermore, the applicant had acknowledged in the form that she was satisfied with the information received and that she understood the scope and risks of the proposed surgery. Law – Article   8: The medical proceedings at issue, namely the removal of the applicant’s NAC in the context of a breast-conserving surgery, was a type of intervention that bore on important aspects of a woman’s personal integrity, including her physical and mental well-being, her image and self-esteem, and her sexual life, which were important elements of the personal sphere protected by Article   8. Consequently, Article   8 was applicable in the circumstances of the present case. The issue at stake was whether the State had complied with the positive obligations under Article   8 to protect the applicant’s right to give informed consent to a medical intervention, namely by putting in place a regulatory framework and ensuring its effective functioning. With regards to the regulatory framework, the Court had already observed that the Spanish domestic law provisions governing the giving of consent were fully in conformity with the corresponding provisions of the Oviedo Convention . Therefore, the Court did not discern any deficiencies in respect of the regulatory framework applicable in the respondent State that could entail a violation of the State’s positive obligations under Article   8. The objective of the breast cancer surgery had been to remove the cancer, if possible in its entirety, including by a surgical margin, and an intraoperative modification of surgical technique might sometimes be necessary to achieve that goal. However, since the applicant had been a mentally competent adult patient, her informed consent had been a prerequisite to the procedure, even assuming that the latter had been a necessity from a medical point of view. The Court had to assess whether, as held by the High Court, the consent given by the applicant could be considered sufficient to cover the modification of surgical technique which had resulted in removal of the NAC. Firstly, although different from the intervention for which the applicant had initially given her consent, the surgical procedure which had been ultimately performed had been also conserving in nature, in so far as it had not entailed the complete removal of the breast. However, the Court considered that it had not been sufficiently clear for a person with no medical knowledge, such as the applicant, which of the surgeries included in the list of possible interventions could be considered as a modification of surgical technique covered by the informed consent form. In particular, it had not been sufficiently clear that a possible modification of the scheduled technique could ultimately include a resection of the NAC and, therefore, that signing the form had resulted in accepting that outcome as a possibility. Secondly, in the Court’s opinion, the mere fact that the applicant had been able to have her doubts clarified in an undocumented interview, with no indication that the possibility of a NAC resection had ever been discussed with her, was insufficient to demonstrate that she had been aware of that possibility and had indeed consented to it. However, the domestic courts had taken no steps to clarify whether the applicant had actually been informed of that possibility. Thirdly, given the nature and purpose of breast-conserving surgery, the general risks and consequences associated with it and with incomplete tumour extirpation, and the applicant’s specific circumstances, the Court considered that the doctors had been required to duly inform her beforehand about the possibility of a NAC resection. Moreover, such an escalation might have significant repercussions for a woman given the importance of the NAC for, inter alia , self-image and sexual life, and thus reinforcing the obligation to inform the patient, so that she could make an informed decision on whether to give consent to any possible removal. In the Court’s opinion, the domestic courts should have been aware of this aspect, in view of the evidence before them showing that the applicant had suffered not only physical consequences, but also a serious psychological impact, resulting from the intervention in question, affecting her emotional wellbeing and sexual life. Nevertheless, no mention had been made of those aspects in the domestic courts’ decisions, thus omitting to take into consideration important dimensions of women’s sexuality. Lastly, the intervention had been planned two weeks in advance and it had not been established in the domestic proceedings that the circumstances during the applicant’s surgery had entailed a life-threatening situation requiring urgent action on the part of the doctors. In the Court’s view, the allegations raised by the applicant before the domestic courts had been of significant importance in establishing the scope of the duty incumbent on the medical professionals involved in her care to seek her informed consent. Regrettably, the domestic courts had not scrutinised them in detail and, therefore, it could not be said that the domestic system had adequately responded to the applicant’s complaint that she had not given her consent to the expansion of the scope of the surgery. The foregoing considerations were sufficient to enable the Court to conclude that the domestic authorities had not provided an adequate response to the applicant’s claim concerning the absence of valid informed consent. Thus, the practical implementation of the existing framework had been deficient and had not afforded sufficient respect for the applicant’s autonomy as protected by Article   8 of the Convention. Conclusion : violation (unanimously). Article   41: no claim in respect of damage. (See Reyes Jimenez v.   Spain , 57020/18, 8   March 2022, Legal Summary ; Pindo Mulla v.   Spain [GC], 15541/20, 17   September 2024, Legal Summary ; Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (CETS 164, the Oviedo Convention) of 4   April 1997   © Council of Europe/European Court of Human Rights This summary by the Registry does not bind the Court. To access legal summaries in English or French click here . For non-official translations into other languages click here .